MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANIX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M005342909
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code 5587:2064 captures the reportable event of stent migration.Imdrf patient code 9213 captures the reportable event of perforation.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.
Event or Problem Description
It was reported to boston scientific that an advanix biliary stent was used for stent placement during a procedure on (b)(6) 2023.At an unknown date, it was found that the stent fell out and perforated the duodenum.It was reported that the migrated stent was removed from the patient.It is unknown if a new stent was implanted.Boston scientific has been unable to obtain additional information, including patient outcome, despite good faith efforts.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17479808
• Report Number: 3005099803-2023-04214
• Device Sequence Number: 11441189
• Product Code: FGE
• UDI-Device Identifier: 08714729787389
• UDI-Public: 08714729787389
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/16/2024
• Device Model Number: M005342909
• Device Catalogue Number: 3429
• Device Lot Number: 0030557025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown